FDA publishes final guidance on serialisation

The US Food and Drug Administration (FDA) has published its final guidance on the use of a serial numbering system to allow individual packs of prescription drugs to be identified, validated and authenticated, as well as allowing track-and-trace through the supply chain.

The requirement for the FDA to develop guidance on serialisation is enshrined in the FDA Amendments Act of 2007, which instructed the agency to develop standards to help secure the supply chain against "counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs."

In January 2009 the agency proffered up its first draft of the guidance, and has now delivered the finalised version within the 30-month deadline for action laid out in FDAAA.

It stresses this is guidance only - recommendations rather than rules - but having a standard will inspire confidence in companies considering serialisation in advance of state mandates such as California's much-delayed ePedigree initiative or future federal initiatives in this area.

The FDA has decided on a standardised numerical identifier (SNI) up to 20 digits (alphanumeric) in length, running alongside the National Drug Code to create a serialised NDC or sNDC that will be used to identify drugs at the unit package level.

GS1-ready

The serial number will not include expiration date and/or lot or batch numbers, says the agency, as this will already be present on the label and this information can be linked to the SNI via a database. However, companies that choose to do so may include this data in accordance with the Global Trade Item Numbers (GTIN) developed by standards body GS1.

"The GTIN is used worldwide by twenty-three industry sectors, including healthcare, and has been adopted by sixty-five countries to uniquely identify pharmaceutical products," says the guidance.

The FDA also says the serial number should be present in both machine- and human-readable forms, but it does not specify the way in which the SNI should be incorporated onto the pack, leaving the path open for both 2D datamatrix and radiofrequency identification (RFID) technologies.

"Most prescription drug product packages already have an NDC on them," says the guidance document. "By combining a serial number of up to 20 characters with the NDC, the sNDC should be sufficiently robust to support billions of units of marketed products without duplication of an SNI."

The guidance document - available to download here - is just one of several guidances and regulations the FDA intends to develop in order to meet the requirements of the FDAAA provisions on supply chain security.